Published: 7 July 2021

COVID-19

Adverse events following immunisation with COVID-19 vaccines: Safety Report #15 – 12 June 2021

• Introduction
• Adverse events following immunisation (AEFI) reported
• Summary of reported deaths
• Adverse events of special interest
• Definitions
• More information

Introduction

This page provides information on the number of adverse events following immunisation (AEFI) reports received for COVID-19 vaccines.

An AEFI is an untoward medical event which follows immunisation and does not necessarily have a causal relationship with the administration of the vaccine. The adverse event may be an unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.

The national roll-out of COVID-19 vaccines commenced on 20 February 2021. The vaccine currently available in New Zealand is Pfizer-BioNTech (Comirnaty). All medicines can cause side effects, the known side effects for Comirnaty are listed in the data sheet and consumer medicine information.

Suspected AEFI to COVID-19 vaccines are reported to the Centre for Adverse Reactions Monitoring (CARM). The Ministry of Health (through Medsafe) contracts the collection of this information to CARM, based at the University of Otago in Dunedin. Medsafe is closely monitoring the AEFI reported from the use of the COVID-19 vaccine. Find out more about vaccine safety monitoring.

Medsafe and CARM thank everyone who has contributed to the monitoring of COVID-19 vaccines. Please continue to report any adverse events following immunisation.

Adverse events following immunisation (AEFI) reported

The information below includes:

• AEFI reports received and vaccine doses administered
• AEFI reports by prioritised ethnicity and vaccine dose
• AEFI reports by age band and vaccine dose
• the top 10 most frequently reported AEFIs by vaccine dose.

AEFI reports received and vaccine doses administered, up to and including 12 June 2021

There were 367 non-serious and 18 serious reports this week. Sadly, one of these serious reports reported on a death. For more information, please refer to the summary of reported deaths. No safety concerns with the Comirnaty vaccine were raised by these reports.

Furthermore, three of the serious reports were described as allergic reactions and one report was for a reactogenicity reaction (flu-like symptoms). The remaining reports were for: myocardial infarction (2), dyspnoea (2), stroke, cerebral haemorrhage, deep vein thrombosis (DVT), pulmonary embolism, pericarditis, tachycardia, atrial fibrillation, syncope, facial paralysis and herpes zoster.

Anaphylaxis

Anaphylaxis is a rare adverse event that can occur with any vaccine. People giving vaccines must have medical treatment for anaphylaxis on hand, and must keep people under observation for at least 20 minutes so that anaphylaxis can be managed, if it happens.

Of the three serious reports of allergic reactions this week, there were no reports where the reporter indicated suspected anaphylaxis.

New safety signal: stroke

Reports of stroke following COVID-19 vaccination have been reported in New Zealand and internationally. The COVID-19 Vaccine Safety Monitoring Board (CV-ISMB) reviewed the locally reported cases as well as international data and considered that the number of cases locally and internationally was no higher than the expected background rate for strokes. The current evidence does not suggest an increased risk of stroke. Medsafe will continue to monitor the issue of stroke through our usual safety monitoring processes.

Ongoing safety signal: menstrual disorder

Reports of menstrual disorders and unexpected vaginal bleeding have been reviewed by the CV-ISMB. The number of reports received is low compared to how many females have been vaccinated and how common these types of disorders are generally. The CV-ISMB considered that the current evidence does not suggest an increased risk of these disorders following vaccination with Comirnaty. Medsafe will continue to monitor reports of menstrual disorders and unexpected vaginal bleeding.

AEFI reports received by prioritised ethnicity and vaccine dose, up to and including 12 June 2021

Ethnicitya	Dose 1	Dose 2	Dose unknownb	Total
Māori	191	151	0	342
Pacific Peoples	147	120	0	267
Asian	453	363	0	816
European/Other	1,799	1,565	0	3,364
Unknownb	63	43	0	106
Total	2,653	2,242	0	4,895c

Notes:

1. The prioritised ethnicity classification system allocates each person to a single ethnic group, based on the ethnic groups they identify with. Where people identify with more than one group, they are assigned in this order of priority: Māori, Pacific Peoples, Asian, and European/Other. So, if a person identifies as being Māori and New Zealand European, the person is counted as Māori. See Ethnicity Data Protocols for further information.
2. There were 106 AEFI reports where the person’s ethnicity was not reported. Ethnicity and dose number are not required for an AEFI report to be considered valid. See ‘Valid report’ in the Definitions section below.
3. The total is different from the cumulative total above because it excludes 2 AEFI reports received for infants who did not receive the vaccine (see safety report 10).

AEFI reports received by age band and vaccine dose, up to and including 12 June 2021

Age	Dose 1	Dose 2	Dose unknowna	Total
10 - 19 years	61	37	0	98
20 - 29 years	476	450	0	926
30 - 39 years	500	516	0	1,016
40 - 49 years	452	472	0	924
50 - 59 years	467	430	0	897
60 - 69 years	366	230	0	596
70 - 79 years	211	64	0	275
80+ years	88	23	0	111
Unknowna	32	20	0	52
Total	2,653	2,242	0	4,895b

Note:

1. There were 52 AEFI reports where the person’s age was not reported. Age and dose number are not required for an AEFI report to be considered valid. See ‘Valid report’ in the Definitions section below.
2. The total is different from the cumulative total above because it excludes 2 AEFI reports received for infants who did not receive the vaccine (see safety report 10).

Top 10 most frequently reported AEFIs, any dose, up to and including 12 June 2021

Reaction	Number
Headache	1,819
Dizziness	1,432
Nausea	1,190
Fever	1,172
Lethargy	1,149
Injection site pain	1,003
Musculoskeletal pain	567
Feeling of body temperature change	449
Numbness	340
Chest discomfort	323

Top 10 most frequently reported AEFIs, dose 1 only, up to and including 12 June 2021

Reaction	Number
Dizziness	842
Headache	751
Nausea	521
Fever	405
Lethargy	401
Injection site pain	349
Numbness	173
Musculoskeletal pain	161
Syncope (fainting)	159
Chest discomfort	153

Top 10 most frequently reported AEFIs, dose 2 only, up to and including 12 June 2021

Reaction	Number
Headache	1,068
Fever	767
Lethargy	745
Nausea	669
Injection site pain	654
Dizziness	590
Musculoskeletal pain	406
Feeling of body temperature change	332
Numbness	167
Myalgia (muscle pain)	161

Please note that one adverse event report, which represents one person, may report on more than one symptom. Reports are sent to CARM if the reporter suspects that the vaccine may have caused the event. This does not necessarily mean that the vaccine did cause the event.

The number of reports can be influenced by how many people are being vaccinated, media attention, the nature of the events (eg, how painful the vaccination was), and other factors which vary over time. Not everyone who has an adverse reaction reports it, and some people may report AEFIs after each vaccination. The information here shows the number of reports not the number of people who experienced an AEFI.

The information is limited by the information provided in the report and may change over time due to quality control procedures and/or receipt of additional information. Non-valid reports are not included in the data.

Summary of reported deaths

Up to and including 12 June 2021, a total of nine deaths were reported to CARM after the administration of the Comirnaty vaccine. Following medical assessments by CARM and Medsafe it has been determined that:

• 5 of these deaths are unlikely related to the COVID-19 vaccine
• 2 deaths could not be assessed due to insufficient information
• 2 cases are still under investigation.

By chance, some people will experience new illnesses or die from a pre-existing condition shortly after vaccination, especially if they are elderly. Therefore, part of our review process includes comparing natural death rates to observed death rates following vaccination, to determine if there are any specific trends or patterns that might indicate a vaccine safety concern. There are currently no indications to suggest that the vaccine caused the deaths.

To date, the observed number of deaths reported after vaccination is actually less than the expected number of deaths.

Adverse events of special interest

Adverse events of special interest (AESI) are pre-specified medically significant events that have the potential to be causally associated with the vaccine and must be carefully monitored. AESI can be serious or non-serious and can include:

• Events of interest due to their association with COVID-19 infection.
• Events of interest for vaccines in general (e.g. to the specific vaccine type or adjuvants).

The list of AESIs below takes into consideration the lists of AESIs from expert groups such as the Brighton Collaboration, manufacturers and other regulatory authorities. The AESI list changes based on the evolving safety profile of vaccines. It is important to note that although these adverse events may occur after being vaccinated with a COVID-19 vaccine in New Zealand, they are rare and may not necessarily be related to the vaccine. Medsafe and CARM review the reports to determine whether the vaccine may have played a role in the occurrence of these events.

Adverse events of special interest (AESI) up to and including 12 June 2021

AESI Category	AESI	Totala
Immune system disorders	Guillain-Barré Syndrome	<6
	Thrombocytopenia	<6
	Thrombosis with thrombocytopenia syndrome (TTS)	0
	Anaphylaxisb	14
Cardiovascular system	Myocardial infarction (heart attack)	<6
	Myocarditis/pericarditis	<6
Blood and lymphatic system	Thrombosis	<6
	Embolism	6
	Deep vein thrombosis (DVT)	9
	Vasculitis	<6
	Haemorrhage	10
Hepato-gastrointestinal and renal system	Acute kidney injury	0
	Acute liver injury	<6
Nervous system	Aseptic meningitis	0
	Encephalitis	0
	Stroke	8
	Bell's Palsy/facial paralysis	14
	Myelitis	0
Infections and musculoskeletal	Erythema multiforme	0
	Arthritis	0
	Herpes zoster	15

1. Includes all reports, both serious and non-serious. Counts below 6 are reported as <6 for privacy reasons.
2. Includes reports meeting levels 1-3 of the Brighton Collaboration case definition.

Definitions

Adverse event following immunisation (AEFI)

An AEFI is an untoward medical event which follows immunisation and does not necessarily have a causal relationship with the administration of the vaccine. The adverse event may be an unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.

Serious adverse event following immunisation

An AEFI is considered serious if it:

• is a medically important event or reaction
• requires hospitalisation or prolongs an existing hospitalisation
• causes persistent or significant disability or incapacity
• is life threatening
• causes a congenital anomaly/birth defect
• results in death.

It is possible for different people to have experienced the same event but for the report to be serious for one person and non-serious for another person.

Adverse events of special interest (AESI)

An AESI is a pre-specified medically significant event that has the potential to be causally associated with the vaccine product based on past experience, the technology used to make the vaccine or the infection the vaccine is used to protect against. AESIs need to be carefully monitored and any potential association to vaccination confirmed by further analysis and studies.

Safety signal

Information on a new or known adverse event that may be caused by the vaccine and requires further investigation. Safety signals can be detected from a wide range of sources such as CARM reports, clinical studies and scientific literature.

Valid report

There are only four requirements for a valid AEFI report:

1. one patient identifier (eg, name, initials, gender, date of birth, age)
2. suspect medicine(s)
3. suspected reaction(s)
4. reporter details.

These four requirements are the minimum requirements. However, including more information in the report helps Medsafe to investigate the reaction more quickly. Reporting is easiest online.

More information

See the data sheets and consumer medicine information for the expected reactions for approved COVID-19 vaccines.

COVID-19 Vaccine Safety Monitoring Process

View Ministry of Health COVID-19 vaccine data

Latest listing of all cases received

The latest listing of AEFIs received is included in the attached spreadsheet. Medsafe advises patients NOT to make any decisions about vaccination based on information contained here.

Download AEFI-line-listing.xlsm